1: Negative amyloid PET study in an elderly patient with cognitive impairment indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer’s disease. 2: Amyloid PET/CT study in a patient with cognitive impairment being evaluated for Alzheimer’s disease and other causes of cognitive decline shows a high level of tracer binding to amyloid plaques in the brain. Images obtained with Siemens Biograph mCT and evaluated with 510(k)-pending syngo.PET Amyloid Plaque software. Source: University of Tennessee, Knoxville, TN

The first sites in the U.S. are providing PET imaging with florbetapir (Amyvid), which can detect the presence or absence of amyloid plaques in the brain as part of a diagnostic evaluation to determine if a patient has the pathology of Alzheimer's disease (AD). Early adopters include Imaging Healthcare Specialists in San Diego County.

Amyvid was FDA approved in April, and released to select imaging centers by Eli Lilly on June 1. In accordance with FDA guidelines, Imaging Healthcare Specialists will limit the scan to people who already have cognitive decline and in conjunction with traditional clinical evaluation.

In the procedure, patients are injected with florbetapir, which binds to amyloid plaques in the brain that are the hallmark of AD. The patient then undergoes PET imaging to detect the presence or absence of amyloid plaque.

“This test is a diagnostic adjunct to other clinical evaluation methods, such as physical examination, laboratory evaluation, and neuropsychiatric/cognitive testing, and should only be used to confirm an AD diagnosis in the cognitively impaired patient. Although this test cannot detect very low levels of amyloid plaque, a negative test means that the cognitive impairment is likely due to some cause other than AD," Mark Schechter, MD, medical director of PET Imaging at Imaging Healthcare Specialists, said in a release.

The news follows the May announcement by Health and Human Services Secretary Kathleen Sebelius of a national plan to fight AD and find effective treatment and prevention methods by 2025.

Currently, health insurance does not cover florbetapir imaging, so patients must pay out of pocket.